[Federal Register Volume 89, Number 34 (Tuesday, February 20, 2024)]
[Notices]
[Pages 12844-12845]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-03348]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifiers: CMS-10110]


Agency Information Collection Activities: Proposed Collection; 
Comment Request

AGENCY: Centers for Medicare & Medicaid Services, Health and Human 
Services (HHS).

ACTION: Notice.

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SUMMARY: The Centers for Medicare & Medicaid Services (CMS) is 
announcing an opportunity for the public to comment on CMS' intention 
to collect information from the public. Under the Paperwork Reduction 
Act of 1995 (PRA), Federal agencies are required to publish notice in 
the Federal Register concerning each proposed collection of information 
(including each proposed extension or reinstatement of an existing 
collection of information) and to allow 60 days for public comment on 
the proposed action. Interested persons are invited to send comments 
regarding our burden estimates or any other aspect of this collection 
of information, including the necessity and utility of the proposed 
information collection for the proper performance of the agency's 
functions, the accuracy of the estimated burden, ways to enhance the 
quality, utility, and clarity of the information to be collected, and 
the use of automated collection techniques or other forms of 
information technology to minimize the information collection burden.

DATES: Comments must be received by April 22, 2024.

ADDRESSES: When commenting, please reference the document identifier or 
OMB control number. To be assured consideration, comments and 
recommendations must be submitted in any one of the following ways:
    1. Electronically. You may send your comments electronically to 
http://www.regulations.gov. Follow the instructions for ``Comment or 
Submission'' or ``More Search Options'' to find the information 
collection document(s) that are accepting comments.
    2. By regular mail. You may mail written comments to the following 
address: CMS, Office of Strategic Operations and Regulatory Affairs, 
Division of Regulations Development, Attention: Document Identifier/OMB 
Control Number: __, Room C4-26-05, 7500 Security Boulevard, Baltimore, 
Maryland 21244-1850.
    To obtain copies of a supporting statement and any related forms 
for the proposed collection(s) summarized in this notice, please access 
the CMS PRA website by copying and pasting the following web address 
into your web browser: https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing.

FOR FURTHER INFORMATION CONTACT: William N. Parham at (410) 786-4669.

SUPPLEMENTARY INFORMATION:

Contents

    This notice sets out a summary of the use and burden associated 
with the following information collections. More detailed information 
can be found in each collection's supporting statement and associated 
materials (see ADDRESSES).

CMS-10110 Manufacturer Submission of Average Sales Price (ASP) Data for 
Medicare Part B Drugs and Biologicals

    Under the PRA (44 U.S.C. 3501-3520), Federal agencies must obtain 
approval from the Office of Management and Budget (OMB) for each 
collection of information they conduct or sponsor. The term 
``collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes agency requests

[[Page 12845]]

or requirements that members of the public submit reports, keep 
records, or provide information to a third party. Section 3506(c)(2)(A) 
of the PRA requires Federal agencies to publish a 60-day notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension or reinstatement of an existing 
collection of information, before submitting the collection to OMB for 
approval. To comply with this requirement, CMS is publishing this 
notice.

Information Collection

    1. Type of Information Collection Request: Revision of currently 
approved collection; Title of Information Collection: Manufacturer 
Submission of Average Sales Price (ASP) Data for Medicare Part B Drugs 
and Biologicals; Use: Section 1847A of the Act requires that the 
Medicare Part B payment amounts for covered drugs and biologicals not 
paid on a cost or prospective payment basis be based upon 
manufacturers' average sales price data submitted quarterly to the 
Centers for Medicare & Medicaid Services (CMS). The reporting 
requirements are specified in 42 CFR part 414 subpart J.
    CMS, specifically, the Division of Data Analysis and Market-based 
Pricing (DDAMBP) will utilize the ASP data (ASP and number of units 
sold as specific in section 1847A of the Act) to determine the Medicare 
Part B drug payment amounts for CY 2005 and beyond. The manufacturers 
submit their ASP data for all of their National Drug Codes (NDC) for 
Part B drugs. DDAMBP compiles the data, analyzes the data and runs the 
data through software to calculate the volume-weighted ASP for all of 
the NDCs that are grouped within a given HCPCS code. The formula to 
calculate the volume-weighted ASP is the Sum (ASP * units) for all 
NDCs/Sum (units * bill units per pkg) for all NDCs. DDAMBP provides ASP 
payment amounts for several components within CMS that utilize 1847(A) 
payment methodologies to implement various payment policies including, 
but not limited to, ESRD, OPPS, OTP and payment models. CMS will also 
use reported ASP and units to calculate inflation adjusted coinsurance 
and rebates. The Department of Health and Human Services' Office of the 
Inspector General also uses the ASP data in conducting studies. Form 
Number: CMS-10110 (OMB Control Number: 0938-0921); Frequency: 
Quarterly; Affected Public: Private and Business or other for-profits; 
Number of Respondents: 500; Number of Responses: 2,00; Total Annual 
Hours: 26,000. (For policy questions regarding this collection contact 
Felicia Brown at (410) 786-9287 or <a href="/cdn-cgi/l/email-protection#490f2c25202a2028672b3b263e27092a243a6721213a672e263f"><span class="__cf_email__" data-cfemail="e7a1828b8e848e86c98595889089a7848a94c98f8f94c9808891">[email protected]</span></a>).

William N. Parham, III,
Director, Division of Information Collections and Regulatory Impacts, 
Office of Strategic Operations and Regulatory Affairs.
[FR Doc. 2024-03348 Filed 2-16-24; 8:45 am]
BILLING CODE 4120-01-P


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